Lung Injury Clinical Trial
Official title:
Effect of Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery
During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a
problem complicating the postoperative course of the patients.Remote ischemic
preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple,
cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that
RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the
RIPC can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is
still uncertain.
The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect
and improve clinical outcomes in patients undergoing cardic surgery.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patients undergoing heart surgery on cardiopulmonary bypass 2. Patients aged 18 years to 80 years Exclusion Criteria: 1. Inability to give informed consent 2. Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted) 3. Prior receipt of chemotherapy or radiation therapy or immunotherapy 4. left ventricular ejection fraction less than 30% 5. preoperative use of inotropics or mechanical assist device 6. Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio) 7. Patients with known renal failure with a GFR<30 mL/min/1.73 m2 8. recent myocardial infarction (within 7 days) 9. Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature>38?) 10. Significant peripheral arterial disease affecting the upper limbs 11. surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery |
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Xuzhou Medical University |
China,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of PaO2/FiO2 over 24 hours after cardiac surgery | 24 hours post surgery | ||
Secondary | All-cause mortality | 30 days post surgery | ||
Secondary | Postoperative Pulmonary Complications | 30 days post surgery |
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